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Medical Devices / Submissions and Approvals

Omron Gains FDA’s Clearance for Blood Pressure Monitor

March 25, 2019

The FDA issued 510(k) clearance to Omron’s blood pressure monitor and electrocardiogram (EKG) device, which provides patients a more complete heart health analysis.

The company said the device is the first of its kind to combine a blood pressure monitor with an EKG tool. The tool lets patients monitor two critical risk factors for stroke, AFIB and high blood pressure.

The device also syncs with the Omron mobile app, giving patients a tool to manage heart health data that can be easily viewed on devices.

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